Overview of the Mandatory Generic Drug Program

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With the exception of drugs subject to the Preferred Drug Program or the Dispense Brand when Less than Generic program, State law
excludes Medicaid coverage of brand name drugs when the Federal Food and Drug Administration (FDA) has approved a generic product,
unless a prior authorization is received. Prescriptions for brand-name drugs, where an A-rated generic equivalent is available, will
require that the prescriber obtain prior authorization for the brand name drug.

Prior Authorization Process

If a prescriber wishes to prescribe a brand name product, and a generic is available, a call to the prior authorization line
at 1-877-309-9493 must be placed. The prescriber or an authorized agent of the prescriber must respond to a series of questions
which identify the prescriber, the patient and the reason for prescribing this drug. An authorized agent is an employee of the
prescribing practitioner and has access to the patient's medical records (i.e. nurse, medical assistant). The prescriber must
write "DAW and Brand Medically Necessary" on the face of the prescription. The prior authorization line is in operation 24 hours a day,
seven days a week.

If an emergency exists and prior authorization has not been obtained by the prescriber and the pharmacist or recipient is
unable to reach the prescriber, an emergency supply may be requested. The pharmacist may obtain a prior authorization for up to a
three-day emergency supply of a brand name drug (subject to other State laws and Medicaid restrictions) by contacting the prior
authorization line at 1-877-309-9493. The pharmacist is expected to follow up with the prescriber to determine future needs.
Once the pharmacist obtains the prior authorization, dispenses and bills the emergency three-day supply, the prescription is no longer valid for any remaining quantity.

Product-Specific Exemption Process

The Commissioner of Health has the authority to exempt specific brand name drugs from the Mandatory Generic Drug Program. In addition, interested parties can submit a request that the Commissioner exempt additional brand name drugs that have a generic equivalent from this requirement. Drugs which are exempt from the Mandatory Generic Drug Program will not require Mandatory Generic prior authorization. A standardized process for interested parties to request an exemption, The New York State Medicaid Mandatory Generic Clinical Exemption Request, has been developed and is available on the Department of Health (DOH) website. The document must be printed, manually completed, and returned by mail to the address shown on the document. The DOH will only accept completed request forms for an exemption to be considered.

The following brand name drugs are exempt from the Mandatory Generic Drug Program:

Clozaril®

Coumadin®

Dilantin®

Gengraf®

Lanoxin®

Levothyroxine Sodium (Unithroid®, Synthroid®, Levoxyl®)

Neoral®

Sandimmune®

Tegretol®

Zarontin®

These exemptions are not meant to discourage generic prescribing. These drugs have been exempted from Mandatory Generic prior authorization requirements based on specific characteristics of the drug and/or disease state generally treated. Their exemption should not be considered an opinion on the bioequivalency of the generic versions.